K230532 is an FDA 510(k) clearance for the RADx Intraoral Appliance for Snoring and Sleep Apnea. This device is classified as a Device, Jaw Repositioning (Class II - Special Controls, product code LQZ).
Submitted by Achaemenid, LLC (Stratford, US). The FDA issued a Cleared decision on July 12, 2023, 135 days after receiving the submission on February 27, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K230532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2023 |
| Decision Date | July 12, 2023 |
| Days to Decision | 135 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQZ - Device, Jaw Repositioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |